Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction

Not Applicable

Completed

• Conditions: Amphetamine Addiction; Craving; Depression, Anxiety
• Interventions: Device: transcranial magnetic stimulation (TMS)

• Registration Number: NCT04993300
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The study aims to test whether transcranial magnetic stimulation (TMS) improves the craving, depression, anxiety and cognitive function during the abstinent period of methamphetamine users.

Detailed Description

Background:

The disease burden of methamphetamine (MA) use is a critical issue in public health, while the abusers increased rapidly in recent years. The effect of medical intervention for MA addiction is still limited, and the cost of psychotherapy is high. In Taiwan, the MA defendant would be sent to the district inspection after the police confirmed the MA abuse. The prosecutor could assess the case to replace the penalty of imprisonment with a suspended sentence, which included one year of addiction treatment in the designated hospital. However, the insufficient treatment of MA addiction resulted in a subsequent high rescinded rate of suspended sentence cases and led people to doubt these medical intervention programs. Hence, the primary mission is to improve the treatment efficacy within the treatment program. Growing evidence has suggested the effectiveness of transcranial magnetic stimulation (TMS) in improving craving, affective symptoms, and cognitive impairment. However, the majority of the studies were conducted in China. Under China's legal system, researchers designed intense TMS treatment programs for MA users, which was not entirely applicable within Taiwan's system. Therefore, the current proposal aims to design a new TMS treatment and evaluate the tolerability, efficacy, and sustained effect of Taiwanese MA users within the suspended sentence.

Methods:

The investigators applied a case-only follow-up study and divided the study into two phases. Fifteen MA users within the suspended sentence who are under the outpatient-based MA abuse treatment program will be recruited. In Phase 1, 15 subjects will be randomly assigned to two TMS intensity groups (80% and 100%). After one TMS treatment session, subjects will be interviewed with the visual analog scale and the tolerability questionnaire to detect their side-effect and the primary effect of craving reduction. After evaluating the side-effect rate and the craving reduction effect, the investigators will select the subsequent TMS treatment program's intensity. In Phase 2, all subjects undergo a four-week TMS treatment program. In Week 1, subjects will attend continuously five daily TMS sessions. In Week 2 to Week 4, subjects are treated once a week. After 8 TMS sessions, the investigators will follow up one month and three months later. The investigators apply the Visual analog scale, Beck depression inventory, Beck anxiety inventory, and Continuous performance test in each intervention and follow-up time point to measure the efficacy and sustain effect of improving craving, depression, anxiety, and cognitive impairment.

Study Timeline

• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-06
• Study Start: 2022-02-17
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transcranial magnetic stimulation (TMS)	transcranial magnetic stimulation (TMS)	This arm constitute of methamphetamine users who undergone abstinent period

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (Taiwanese version)	20 weeks	Respondents will specify their level of craving from none to extreme on a 100 mm line (score: 0-10) in each questionnaires, and there are nine questionnaires related to craving.

Secondary Outcome Measures

Name	Time	Method
Cognitive function	20 weeks	Continuous performance test was developed by Rosvold and designed as a computerized test of cognitive function.
Tolerance	20 weeks	The respondents will specify five physical symptoms which might related to rTMS intervention (Yes/No: headache, local pain/discomfort, head/face pain/discomfort, seizure, hearing loss/ear ache)
The Beck depression inventory (Taiwanese version BDI)	20 weeks	The Beck depression inventory (Taiwanese version BDI) will be applied to evaluate the depression during the period of methamphetamine abstinence. (Total score: 0-63)
The Beck anxiety inventory (Taiwanese version BAI)	20 weeks	The Beck anxiety inventory (Taiwanese version BAI) will be applied to evaluate the anxiety during the period of methamphetamine abstinence. (Total score: 0-63)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan